Quoin Pharmaceuticals Ltd (QNRX) 2023 Q3 法說會逐字稿

Good day, and welcome to the Quoin Pharmaceuticals third-quarter financial results and business update conference call. (Operator Instructions) Please note this event is being recorded.

美好的一天，歡迎參加 Quoin Pharmaceuticals 第三季財務業績和業務更新電話會議。 （操作員說明）請注意此事件正在被記錄。

I would now like to turn the conference over to Gordon Dunn, Chief Financial Officer. Please go ahead.

我現在想將會議交給財務長戈登鄧恩 (Gordon Dunn)。請繼續。

Thank you, and good morning. We appreciate you joining us on today's conference call.

謝謝你，早安。我們感謝您參加今天的電話會議。

With me on the call are Dr. Michael Myers, CEO; and Denise Carter, COO. We're pleased to provide an update on our progress for the third quarter of 2023, as well as discussing our Q3 2023 financial results. Please note that our operations and financial results press release is now available on Quoin's website.

與我一起參加電話會議的是執行長 Michael Myers 博士；和首席營運官丹尼斯卡特。我們很高興提供 2023 年第三季度進展的最新信息，並討論 2023 年第三季度的財務業績。請注意，我們的營運和財務業績新聞稿現已發佈在 Quoin 網站上。

In keeping with our normal procedure, Michael will first provide an operations update, following which I will review our financial results. I'll then hand the call back to Michael for closing comments before we open the phone lines for questions.

按照我們的正常程序，邁克爾將首先提供營運最新情況，然後我將審查我們的財務表現。然後，在我們打開電話線路提問之前，我會將電話轉回給邁克爾以結束評論。

I'd like to remind everyone that statements made during this conference call will include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties that can cause actual results to differ materially from the information expressed or implied by these forward-looking statements. For more information regarding such risks and uncertainties, please see the risk factors outlined in the company's filings with the SEC.

我想提醒大家，本次電話會議期間發表的聲明將包括1995 年《私人證券訴訟改革法案》含義內的前瞻性聲明，其中涉及風險和不確定性，可能導致實際結果與所表達的信息存在重大差異或這些前瞻性陳述所暗示的。有關此類風險和不確定性的更多信息，請參閱該公司向 SEC 提交的文件中概述的風險因素。

Any forward-looking statements are made only as of today, and we disclaim any obligation to update these forward-looking statements other than as required by law. Please see the Forward-Looking Statements section in our financial results release issued this morning for more information.

任何前瞻性陳述僅截至今日作出，除法律要求外，我們不承擔任何更新這些前瞻性陳述的義務。請參閱今天上午發布的財務業績新聞稿中的前瞻性陳述部分，以了解更多資訊。

It is now my pleasure to turn the call over to our CEO, Michael Myers.

現在我很高興將電話轉給我們的執行長邁克爾·邁爾斯。

Thank you, Gordon, and good morning, everyone. During this past quarter, we continued to make significant progress across multiple fronts, culminating in the release of additional positive clinical data for QRX003 from our ongoing open-label clinical trial in Netherton syndrome after the quarter ended on October 24.

謝謝戈登，大家早安。在過去的這個季度中，我們繼續在多個領域取得重大進展，最終在 10 月 24 日季度結束後，我們正在進行的 Netherton 綜合徵開放標籤臨床試驗中發布了 QRX003 的更多積極臨床數據。

I will spend some time discussing this data, as well as our newly updated and optimized clinical plans for QRX003, which we are now pursuing as a result of this positive development. We believe that these planned protocol amendments will result in an even more robust clinical data set and potentially lead to a faster and possibly wider initial regulatory approval for the product.

我將花一些時間討論這些數據，以及我們新更新和優化的 QRX003 臨床計劃，由於這一積極的發展，我們現在正在追求該計劃。我們相信，這些計劃中的方案修訂將產生更強大的臨床數據集，並有可能導致該產品更快、更廣泛的初始監管批准。

During the quarter, we entered into our ninth commercial partnership for QRX003 with the signing of an agreement with FarmaMondo for Singapore. This new agreement increases the number of countries that we have entered into commercial partnerships for the product to 61. Furthermore, we are currently in late-stage discussions to enter into similar partnerships for additional countries in Southeast Asia and Latin America. This diligent and systematic approach to entering into commercial partnerships is entirely in keeping with our spoken mission to ensure that QRX003 will be made available to as many patients in as many countries as possible once approved.

本季度，我們與 FarmaMondo 簽署了新加坡協議，為 QRX003 建立了第九次商業合作夥伴關係。這項新協議使我們與該產品建立商業合作夥伴關係的國家數量增加到 61 個。此外，我們目前正在後期討論與東南亞和拉丁美洲的其他國家建立類似的合作夥伴關係。這種建立商業合作夥伴關係的勤奮和系統的方法完全符合我們的口頭使命，即確保 QRX003 一旦獲得批准，將向盡可能多的國家的盡可能多的患者提供。

As noted previously, these partnerships, along with our own planned commercial infrastructure for the US and Europe, will facilitate what will effectively amount to a global launch of the product once approved and also lay the foundation for similar global launches of our pipeline products once they also receive regulatory approval. We firmly believe that this global commercial network is unprecedented for a company our size and represents highly differentiated and perhaps somewhat underappreciated advantage for Quoin. The potential incremental revenue-generating opportunity that this global commercial partnership network represents for our company, all of which will effectively fall to the bottom line, could ultimately be highly significant for the company and have a materially positive impact on our future profitability.

如前所述，這些合作夥伴關係以及我們自己計劃的美國和歐洲商業基礎設施，將促進該產品一旦獲得批准，將有效地在全球範圍內推出，並為我們的管道產品在全球範圍內推出類似的產品奠定基礎。也獲得監管部門的批准。我們堅信，對於我們這樣規模的公司來說，這個全球商業網絡是前所未有的，並且代表了 Quoin 高度差異化的、或許有些被低估的優勢。這個全球商業合作夥伴網絡為我們公司帶來了潛在的增量創收機會，所有這些都將有效地落入利潤底線，最終可能對公司非常重要，並對我們未來的盈利能力產生重大積極影響。

During our last call, I also updated everyone on our M&A strategy. As discussed, given our strong balance sheet and potential access to additional capital, we have been acutely focused on expanding our product portfolio via acquisition, licensing, or other means.

在上次電話會議中，我也向大家介紹了我們的併購策略。正如所討論的，鑑於我們強大的資產負債表和獲得額外資本的潛力，我們一直專注於透過收購、授權或其他方式擴大我們的產品組合。

Following an extensive and broad-based process throughout this year, where we assessed well over 20 different opportunities, during the past quarter, we successfully narrowed that list down to three specific products for which we ultimately reached agreement on all key financial terms. As we have stated previously, while there can be no guarantees that the transaction will be consummated, as there are external impacting factors, in particular, current market conditions which, to say the least, are decidedly unfavorable, we are actively working towards closing out at least one transaction as expeditiously as possible. While I'm not in a position to provide any specific details, I can tell you that all three assets are rare disease products that would strongly complement and enhance our current product portfolio.

經過今年廣泛且基礎廣泛的流程，我們評估了 20 多個不同的機會，在上個季度，我們成功地將清單縮小到三個特定產品，並最終就所有關鍵財務條款達成了一致。正如我們之前所說，雖然不能保證交易一定會完成，但由於存在外部影響因素，特別是當前的市場狀況，至少可以說是絕對不利的，但我們正在積極努力完成交易盡快完成至少一項交易。雖然我無法提供任何具體細節，但我可以告訴您，這三種資產都是罕見疾病產品，將有力地補充和增強我們目前的產品組合。

We hope to provide additional information on these opportunities in due course. I do want to make one key point clear, however. We do not intend to close out any such transaction unless and until we have clear visibility on our ability to raise the necessary funds to fully support the clinical development of these assets. The last thing that we will do as a company is to acquire our licensed assets for which we cannot fund the clinical development of.

我們希望在適當的時候提供有關這些機會的更多資訊。不過，我確實想澄清一個關鍵點。我們不打算結束任何此類交易，除非我們清楚地了解我們籌集必要資金以全力支持這些資產的臨床開發的能力。作為一家公司，我們要做的最後一件事就是收購我們無法為其臨床開發提供資金的授權資產。

As we have now stated on previous calls, another company has filed an IND with the FDA and received a study may proceed (technical difficulty) to initiate the clinical development of their product as a potential treatment for Netherton syndrome. As of this morning, following a review of the clinicaltrials.gov website, it appears that this study still has not been initiated, and Quoin remains the only company to be actively conducting clinical studies in Netherton syndrome under an open investigational new drug application or IND.

正如我們在先前的電話中所述，另一家公司已向FDA 提交了IND 申請，並收到了一項可能會繼續進行的研究（技術難度），以啟動其產品的臨床開發，作為Netherton 綜合徵的潛在治療方法。截至今天上午，經過對 ClinicalTrials.gov 網站的審查，這項研究似乎仍未啟動，而 Quoin 仍然是唯一一家在開放研究性新藥申請或 IND 下積極開展 Netherton 綜合徵臨床研究的公司。

Furthermore, while other companies have also spoken for some time, either about filing INDs or initiating Netherton syndrome clinical studies under open INDs, we continue to see a consistent pattern of those timelines either being pushed further and further out or indeed being abandoned completely. As we continue to make significant progress on the clinical front ourselves, we and our now nine global marketing partners are more excited than ever by the potential commercial opportunity that -- of what could be the first regulatory approved product for this horrendous disease.

此外，雖然其他公司也已經談論了一段時間，無論是提交IND 或在開放IND 下啟動Netherton 綜合徵臨床研究，但我們仍然看到這些時間表的一致模式，要么被推得越來越遠，要么實際上被完全放棄。隨著我們繼續在臨床方面取得重大進展，我們和我們現在的九個全球行銷合作夥伴對潛在的商業機會比以往任何時候都更加興奮——這可能是第一個獲得監管機構批准的治療這種可怕疾病的產品。

As we have consistently stated, Quoin, unlike many of our biotech peers, focuses not only on the clinical aspects of product development, but also on the CMC side of development as well. I'm pleased to announce today that our contract manufacturer, our CMO, for the active ingredient in QRX003 has successfully developed and scaled up a new and fully GMP manufacturing process for the drug substance.

正如我們一貫指出的那樣，Quoin 與許多生物技術同行不同，它不僅關注產品開發的臨床方面，還關注開發的 CMC 方面。我今天很高興地宣布，我們的 QRX003 活性成分合約製造商 CMO 已成功開發並擴大了該原料藥的全新且完全 GMP 生產流程。

You may recall that the active ingredient in QRX003, although a very well-characterized molecule, has never been approved as a drug for any indication and that there has been no source of GMP quality material previously available. As a result of this successful collaboration with our CMO, that is no longer the case, and the availability of fully GMP material from a scaled up manufacturing process for the active ingredient represents yet another positive step forward in the development of our product.

您可能還記得，QRX003 中的活性成分雖然是一種特徵非常明確的分子，但從未被批准為任何適應症的藥物，而且之前也沒有可用的 GMP 品質材料來源。由於與我們的 CMO 成功合作，這種情況已不再是這樣，並且透過活性成分的擴大生產過程獲得完全 GMP 材料代表了我們產品開發中又向前邁出了積極的一步。

Bear in mind that this source of GMP material is exclusively contractually available to Quoin only. We are also actively exploring whether new intellectual property may be developed from this exciting development.

請記住，這種 GMP 材料來源僅透過合約提供給 Quoin。我們也正在積極探索是否可以從這令人興奮的發展中開發出新的智慧財產權。

Turning now to our ongoing clinical studies in Netherton syndrome patients. On October 24, we announced the release of positive clinical data from our single-arm open-label study. This data was from the first six evaluable subjects in the study.

現在轉向我們正在進行的針對內瑟頓症候群患者的臨床研究。 10 月 24 日，我們宣布發佈單臂開放標籤研究的積極臨床數據。該數據來自該研究中前六名可評估的受試者。

As outlined in our press release on that date, the data was positive across several measured endpoints. Recall that in this open-label study, subjects are currently receiving off-label systemic treatment and will continue to do so in conjunction with QRX003 for the duration of the study. It is worth noting that all subjects in this study have been treated with this off-label systemic therapy for at least one year and, in a number of cases, for multiple years. Notwithstanding, this ongoing and long-term systemic therapy treatment, all patients recruited into the study exhibited clear signs of Netherton syndrome at the point of entry into the study, including compromised skin and significant pruritus or itch.

正如我們當天的新聞稿中所述，多個測量終點的數據都是正面的。回想一下，在這項開放標籤研究中，受試者目前正在接受標籤外全身治療，並將在研究期間繼續與 QRX003 聯合治療。值得注意的是，本研究中的所有受試者都接受了這種超說明書全身治療至少一年，在許多情況下甚至長達數年。儘管進行了這種持續且長期的全身治療，但所有納入研究的患者在進入研究時都表現出明顯的內瑟頓綜合徵體徵，包括皮膚受損和明顯的瘙癢或瘙癢。

As a result of this long-term systemic therapy, subjects recruited into the study provided a natural baseline for us to assess if treatment with QRX003 over a duration of 12 weeks would lead to any therapeutic improvement across a number of clinical endpoints. As reported, for five of the six subjects, their pruritus RH was either absent or negligible according to the standardized scoring system after treatment with QRX003. Absent or negligible pruritus is defined as a zero or very low single-digit score in a zero to ten scoring range. For the sixth subject, their pruritus was effectively unchanged from baseline on completion of the study, possibly reflecting a not uncommon refractory nature of the pruritus associated with this disease in their particular case.

由於這種長期的全身性治療，招募到該研究的受試者為我們提供了一個自然的基線，以評估 QRX003 在 12 週內的治療是否會導致多個臨床終點的治療改善。據報道，根據標準化評分系統，在使用 QRX003 治療後，六名受試者中的五名受試者的 RH 搔癢要么不存在，要么可以忽略不計。不存在或可忽略的搔癢被定義為零或非常低的個位數分數（在零到十的評分範圍內）。對於第六名受試者，在研究完成時，他們的搔癢與基線相比實際上沒有變化，這可能反映了在他們的特定病例中與這種疾病相關的搔癢的常見難治性。

We are extremely pleased with these results as pruritus can be extremely distressing and debilitating for Netherton patients. What is particularly noteworthy is that despite receiving long-term off-label systemic therapy, all six subjects were experiencing significant pruritus at baseline, and for five of those six, that pruritus had largely disappeared following treatment with QRX003.

我們對這些結果非常滿意，因為搔癢對 Netherton 患者來說可能會帶來極大的痛苦和虛弱。特別值得注意的是，儘管接受了長期的標籤外全身治療，所有六名受試者在基線時都經歷了明顯的瘙癢，而這六名受試者中的五名在接受QRX003 治療後瘙癢基本上消失了。

In addition, all six subjects evaluated demonstrated an improvement in skin appearance according to the investigator's scoring system. For three of the six patients, there was a well-defined improvement in skin appearance according to this endpoint on completion of dosing with QRX003, while for the other three subjects, there were signs of improvement in skin appearance at various points throughout the study, though, not necessarily on completion of testing. This is potentially further important evidence of the possible efficacy of QRX003 as a treatment for NS.

此外，根據研究者的評分系統，所有六名接受評估的受試者都表現出皮膚外觀的改善。對於六名患者中的三名，在完成 QRX003 給藥後，根據該終點，皮膚外觀出現明顯改善，而對於其他三名受試者，在整個研究的不同時間點都有皮膚外觀改善的跡象，但不一定是在測試完成後。這可能是 QRX003 作為 NS 治療藥物可能功效的進一步重要證據。

Importantly also, all six subjects expressed satisfaction with QRX003 across a number of assessed metrics, leading to a positive overall experience with the product. As you know, QRX003 is an easily applied and user-friendly topical lotion, which makes it attractive to use for patients and caregivers. Finally, and also importantly, there were no significant adverse events reported throughout the study, and the overall safety profile of QRX003 to date is extremely favorable and highly suggestive of a potentially safe treatment for this disease.

同樣重要的是，所有六名受試者都對 QRX003 的多項評估指標表示滿意，從而對該產品產生了積極的整體體驗。如您所知，QRX003 是一種易於使用且用戶友好的外用洗劑，這使其對患者和照護者的使用具有吸引力。最後，同樣重要的是，整個研究過程中沒有報告任何重大不良事件，並且迄今為止 QRX003 的整體安全性狀況非常有利，並且高度暗示了該疾病的潛在安全治療方法。

Taken together, the body of clinical evidence generated to date, from both an efficacy and a safety perspective, has led to a number of exciting developments for our two ongoing clinical studies, enabling us to move into an optimization phase, which we believe may ultimately result in an even more robust and diverse data set and potentially to a faster approval for the product. These new developments have been submitted to our open IND for QRX003, and I will now provide some details of these planned protocol amendments.

總而言之，從功效和安全性的角度來看，迄今為止產生的臨床證據為我們正在進行的兩項臨床研究帶來了許多令人興奮的進展，使我們能夠進入優化階段，我們相信這最終可能會實現。產生更強大和多樣化的數據集，並有可能更快地批准產品。這些新進展已提交給我們 QRX003 的開放 IND，我現在將提供這些計劃的協議修訂的一些細節。

One such amendment is the elimination of the lower 2% dose from our double-blinded study. This decision was based on the very clean safety profile observed to date for the higher 4% dose across both studies. Going forward, the double-blinded study will now comprise of the higher 4% dose and a placebo and, as such, will become a two-arm study instead of the current three-arm study that it is.

其中一項修訂是從我們的雙盲研究中取消了 2% 的較低劑量。這項決定是基於迄今為止在兩項研究中觀察到的 4% 較高劑量的非常清晰的安全性。展望未來，雙盲研究現在將包括更高的 4% 劑量和安慰劑，因此將成為一項雙臂研究，而不是目前的三臂研究。

In addition, with a view to maximizing the potential clinical performance of QRX003, we are modifying the dosing frequency of the product from once-daily to twice-daily across both studies. Again, based on the body of clinical evidence generated to date, in conjunction with the very clean safety profile observed so far, we believe that twice-daily dosing of the product has the potential to deliver a more robust clinical evidence of efficacy across all measured endpoints.

此外，為了最大限度地發揮 QRX003 的潛在臨床表現，我們正在兩項研究中將該產品的給藥頻率從每日一次修改為每日兩次。同樣，根據迄今為止產生的臨床證據，結合迄今為止觀察到的非常乾淨的安全性概況，我們相信該產品每天兩次給藥有可能在所有測量的療效中提供更可靠的臨床證據。端點。

Finally, the number of subjects in the open-label study will be increased from the current 10 to 20, with all new subjects being tested with QRX003 dosed twice daily going forward. For the blinded study, the number of subjects to be enrolled will be increased from the original 18 to 30, and going forward, this will be a two-leg study with QRX003 at a 4% dose tested against a placebo, with both test materials now being applied twice daily.

最後，開放標籤研究的受試者數量將從目前的 10 名增加到 20 名，所有新受試者將接受每天兩次 QRX003 的測試。對於盲法研究，入組受試者人數將從原來的 18 名增加到 30 名，今後，這將是一項雙腿研究，以 4% 劑量的 QRX003 與安慰劑進行測試，兩種測試材料現在每天使用兩次。

This now means that both studies will each have a cohort of subjects dosed once daily and a second cohort dosed twice daily, enabling us to evaluate if increasing the frequency of dosing does indeed lead to an incremental therapeutic benefit for subjects in the studies. We are very excited about these new developments in our clinical programs, and as discussed, we believe these protocol amendments may ultimately result in a faster approval for QRX003 in Netherton syndrome and with a more compelling data set.

現在這意味著這兩項研究將分別有一組受試者每天給藥一次，第二組受試者每天給藥兩次，使我們能夠評估增加給藥頻率是否確實會給研究中的受試者帶來增量的治療益處。我們對臨床計畫中的這些新進展感到非常興奮，正如所討論的，我們相信這些方案修訂可能最終會導致 QRX003 治療 Netherton 綜合徵的速度更快獲得批准，並擁有更引人注目的數據集。

With that update on our operational progress, I will now ask Gordon to discuss our third-quarter financial results. Gordon?

在更新我們的營運進度後，我現在請戈登討論我們第三季的財務表現。戈登？

Thank you, Michael. As of September 30, our cash and marketable securities was approximately $14 million, compared to $15.4 million as of June 30, which we expect will be sufficient to fund our operations through the end of 2024.

謝謝你，麥可。截至 9 月 30 日，我們的現金和有價證券約為 1,400 萬美元，而截至 6 月 30 日為 1,540 萬美元，我們預計這將足以為我們的營運提供資金直至 2024 年底。

Our operating loss for the third quarter was $2.1 million, compared to $2.3 million for the third quarter of 2022. The decrease was primarily due to lower professional fees and other general and administrative costs in the quarter.

我們第三季的營運虧損為 210 萬美元，而 2022 年第三季為 230 萬美元。這一下降主要是由於本季專業費用以及其他一般和管理成本的降低。

I'll now turn the call back to Michael to make some closing remarks and begin our Q&A.

現在我將把電話轉回給邁克爾，讓他做一些結束語並開始我們的問答。

Thank you, Gordon. We are entering a very exciting period for Quoin. Based on the positive clinical data reported recently, we are making a number of protocol adjustments to our ongoing clinical studies, which we believe may lead to a more rapid approval with a broader and more robust data set.

謝謝你，戈登。對於 Quoin 來說，我們正在進入一個非常令人興奮的時期。根據最近報告的積極臨床數據，我們正在對正在進行的臨床研究進行一些方案調整，我們相信這可能會透過更廣泛、更可靠的數據集帶來更快的批准。

In addition, following a thorough process throughout the year, we have identified and agreed financial terms for the acquisition or licensing of a number of exciting new assets in the rare and orphan disease space that we believe could be highly complementary to our current development portfolio. While we are diligently working on finalizing at least one transaction as soon as possible, there can be no assurances that this will actually occur, as we will only close out any deal if we can raise the incremental funds required to complete the clinical development for that asset.

此外，經過全年的徹底流程，我們已經確定並商定了罕見疾病和孤兒疾病領域一些令人興奮的新資產的收購或許可的財務條款，我們相信這些新資產可以與我們當前的開發組合高度互補。雖然我們正在努力盡快完成至少一項交易，但不能保證這確實會發生，因為只有當我們能夠籌集完成臨床開發所需的增量資金時，我們才會完成任何交易資產。

We intend to use our current funds primarily to advance the development of QRX003 and our order pipeline products only, and the development of any additional products will need to be funded by new capital. We believe that in these highly challenging market conditions, such prudent use of our cash resources must remain a key priority for the company as we head into 2024.

我們打算將現有資金主要用於推進 QRX003 和我們的訂單管道產品的開發，任何其他產品的開發都需要透過新資本提供資金。我們相信，在充滿挑戰的市場條件下，在進入 2024 年時，謹慎使用現金資源仍然是公司的首要任務。

With that, operator, we are now ready for questions.

接線員，現在我們準備好提問了。

(Operator Instructions) James Molloy, Alliance Global Partners.

（操作員說明）James Molloy，Alliance Global Partners。

Hey, guys. Good morning. Thank you for taking my questions. I had a question on the changes to the Phase 2/3 trial from 10 to 20 and from two arms to one arm and changing the doses. I think expectations are for mid-24 data, does this change the expectation for being able to file potentially should the data bear up based on this trial in, say, late '24?

大家好。早安.感謝您回答我的問題。我對 2/3 期試驗從 10 例改為 20 例、從兩隻手臂改為一隻手臂以及改變劑量有疑問。我認為預期是 24 年中期的數據，如果數據在 24 年末等試驗中得到證實，這是否會改變對能夠提交文件的預期？

Hi, James. So thanks for the question, and thanks for participating. We don't believe there's going to be any material change to the timelines. It does affect the pace at which data will be released, but overall, we believe we remain on track and possibly able to speed up the approval of the product. So these developments are positive overall.

嗨，詹姆斯。謝謝你的提問，也謝謝你的參與。我們認為時間表不會有任何重大變化。它確實會影響資料發布的速度，但總的來說，我們相信我們仍處於正軌，並且可能能夠加快產品的批准速度。因此，這些進展總體上是積極的。

Okay, thank you. And then on the timing of bringing in this -- the one transaction that you see very close on, can you walk through again, presuming -- you mentioned you'd only bring it in if you could raise the funds to do so. Can you walk through, in an ideal world, when you would like to bring that in, and how much you think it would take -- you need to raise to get that through from the trials?

好的謝謝。然後，關於引入這項交易的時機——您看到非常接近的一筆交易，您可以再次回顧一下嗎？假設——您提到，只有在您能夠籌集資金的情況下，您才會引入它。在理想的世界裡，當你想引入這一點時，你能想像一下嗎？你認為需要多少錢——你需要籌集資金才能通過考驗？

Yeah. So I'm not going to get into any details, James, about how much it would take to complete the clinical development of the product on this call. In an ideal world, I would like to get this closed prior to the end of the year. As you well know, we're not living in an ideal world at the moment, so I can't really give a timeline. I could just say, look, we have agreed financial terms that we believe are favorable to Quoin, so we're excited about that.

是的。因此，詹姆斯，我不會在這次電話會議上詳細介紹完成產品的臨床開發需要多少錢。在理想的情況下，我希望在今年年底之前完成此任務。如你所知，我們目前並不生活在一個理想的世界中，所以我無法給出一個時間表。我只能說，看，我們已經就財務條款達成一致，我們認為這些條款對 Quoin 有利，所以我們對此感到興奮。

And we think this asset has the potential to be a very significant commercial product once approved, but there are other factors at play here that are somewhat outside of our control. So we will remain diligent, but we will remain focused on ensuring that we don't put ourselves in a position where we bring in a new asset and it has to sit on our shelf because we can't fund the development of it. So I would ask you to be patient and hang in there as we work through the process.

我們認為，一旦獲得批准，該資產就有可能成為非常重要的商業產品，但這裡還有其他因素在起作用，這些因素在某種程度上超出了我們的控制範圍。因此，我們將繼續努力，但我們將繼續專注於確保我們不會陷入這樣的境地：我們引入了新資產，但它卻因為我們無法為其開發提供資金而不得不束之高閣。因此，我要求您在我們完成整個過程時保持耐心並堅持下去。

Absolutely. Maybe last question to you, any updates -- I know you're obviously focused in (inaudible) on Netherton QRX003. Any updates on 004, 007, 008, for the other various early-stage programs? Are those sort of on-hold finance?

絕對地。也許最後一個問題是關於任何更新 - 我知道您顯然專注於（聽不清楚）Netherton QRX003。 004、007、008 以及其他各種早期項目有什麼更新嗎？這些是暫停融資嗎？

So 004, which you know is our program for EB, remains on hold as we continue to evaluate the commercial opportunity for our product. There has been developments in this space in the past year. There's been approval here in the US. There was a product that was approved in Europe, though rejected in the US. And there are some other pivotal data that should come out in the next several months as well. So we remain vigilant, we remain watchful, but not putting any resources into that at this point.

因此，004（您知道是我們的 EB 計劃）仍處於擱置狀態，因為我們將繼續評估我們產品的商業機會。去年，這個領域取得了一些進展。美國已經批准了。有一種產品在歐洲獲得批准，但在美國被拒絕。還有一些其他關鍵數據也應該在未來幾個月內公佈。因此，我們保持警惕，保持警惕，但目前不會投入任何資源。

07 and 08 continue to make progress with our partnership with Queens University of Technology in Australia. As we have said for quite some time now, these are early-stage programs and on a different trajectory than 03, but we believe, ultimately, they could be important contributors as well. So moving forward, but as I said, at a different pace than 03.

07年和08年我們與澳洲皇后科技大學的合作關係持續取得進展。正如我們長期以來所說，這些都是早期項目，與 03 的發展軌跡不同，但我們相信，最終它們也可能成為重要的貢獻者。所以繼續前進，但正如我所說，與 03 的步伐不同。

Great. Thank you for taking the questions.

偉大的。感謝您提出問題。

Thanks, Jim.

謝謝，吉姆。

(Operator Instructions) M. Marin, Zacks.

（操作員說明）M. Marin，Zacks。

Thank you. So the clinical data, you've done a very strong job in securing distribution. As you said, you have nine agreements in place. The clinical data that you've reported, do you expect that this will accelerate conversations with other potential distribution partners?

謝謝。因此，從臨床數據來看，你們在確保分發方面做得非常出色。正如你所說，你們已經達成了九項協議。您報告的臨床數據是否會加速與其他潛在經銷合作夥伴的對話？

Great question. So thank you for asking, [Marin]. Potentially, yes, we receive a lot of inbound interest regarding this product. We've consistently said we will commercialize ourselves in the US and Europe, but still, there's a lot of interest from companies who have an established infrastructure and like where the product is going. So I think you're right. It will increase interest. We're hoping that interest will be in countries where we haven't partnered, though to be honest, there aren't that many of them left at this point. So I think the short answer is yes.

很好的問題。謝謝你的提問，[馬林]。是的，我們可能會收到很多對該產品的興趣。我們一直表示，我們將在美國和歐洲進行商業化，但擁有成熟基礎設施並喜歡產品發展方向的公司仍然表現出極大的興趣。所以我認為你是對的。它會增加興趣。我們希望那些尚未與我們合作的國家能夠引起人們的興趣，不過說實話，目前這樣的國家已經所剩無幾了。所以我認為簡短的答案是肯定的。

Okay. Thank you.

好的。謝謝。

[Dennis Panolo, Lapin Partners].

[丹尼斯·帕諾洛，Lapin Partners]。

Hi. Good morning, gentlemen. Thank you for taking my question. My first question -- I'm sure you guys have done some back-of-the-envelope math and figured out some price points. Could you tell us a little bit about your total addressable market, the TAM, for the NS product?

你好。早安，先生們。感謝您回答我的問題。我的第一個問題——我相信你們已經做了一些粗略的數學計算併計算出了一些價格點。您能否告訴我們一些有關 NS 產品的總目標市場 TAM 的資訊？

Hi, Dennis. Thanks for the call. Nice to meet you again.

嗨，丹尼斯。感謝您的來電。很高興再次見到您。

So we believe, combined in US and Europe, there's probably somewhere between 7,000 to 8,000 patients. And in the countries that we've partnership, there's probably an additional 10,000 to 15,000. Numbers are difficult to come by, as I'm sure you know because this is a very rare disease, and diagnosis can be challenging, but these are numbers that we feel pretty confident with.

因此我們相信，美國和歐洲加起來可能有 7,000 到 8,000 名患者。在我們有合作關係的國家中，可能還有 10,000 到 15,000 個。數字很難獲得，我相信您知道，因為這是一種非常罕見的疾病，診斷可能具有挑戰性，但我們對這些數字非常有信心。

In terms of price point, we haven't drilled down to a point where I'm comfortable saying -- giving you an exact number. But the opportunity here, we believe, is substantially in excess of $500 million in total and could be significantly higher.

就價格點而言，我們還沒有深入到我可以輕鬆說出的地步——給你一個確切的數字。但我們相信，這裡的機會總額遠遠超過 5 億美元，而且可能會更高。

That's a pretty strong number. And my last question is, you were talking about acquiring some more assets or another company. Now, with your company trading for $0.30 on the dollar for your cash, how are some companies not knocking your door down trying to get you guys -- to buy you guys up? I mean, rare disease drugs aren't easy to come by, especially you're so far down the pipeline compared to your competitors.

這是一個相當強勁的數字。我的最後一個問題是，您正在談論收購更多資產或另一家公司。現在，你的公司以 0.30 美元的價格換取你的現金，為什麼有些公司不會敲開你的大門，試圖讓你們收購你們？我的意思是，罕見疾病藥物並不容易取得，尤其是與競爭對手相比，您的研發進度還遠遠落後。

Another great question, and one I can't really provide any details on. But I think you've hit a nail on the head. People are looking at this company, see what we're doing. But we are just focused on what's in front of us. We believe we have a great asset. We're looking to add to that asset with additional products, and we will continue to deliver whatever conversations come our way. We have a Board of Directors to address that.

另一個很好的問題，我無法提供任何細節。但我認為你已經擊中要害了。人們正在關注這家公司，看看我們在做什麼。但我們只專注於眼前的事。我們相信我們擁有巨大的資產。我們希望透過其他產品來增加該資產，並且我們將繼續提供我們遇到的任何對話。我們有一個董事會來解決這個問題。

Okay -- which makes sense, I mean, so if offers are coming in, you guys are looking at them.

好吧——我的意思是，這是有道理的，所以如果有報價，你們就會關注它們。

Not going to comment. But I think you can see where we're going.

不打算發表評論。但我想你可以看到我們要去哪裡。

No, I appreciate it. You guys are just so undervalued, it's ridiculous. I mean, you're getting the pipeline for free, and like I said, you're getting all your cash for $0.30 on a dollar makes very little sense. Anyway, thank you, and have a great day, and look forward to some updates.

不，我很感激。你們的價值被低估了，太可笑了。我的意思是，你可以免費獲得管道，就像我說的，你以 1 美元 0.30 美元的價格獲得所有現金，這是沒有意義的。無論如何，謝謝您，祝您有美好的一天，並期待一些更新。

Thanks, Dennis. Take care.

謝謝，丹尼斯。小心。

With no questions, this concludes our question-and-answer session. I would like to turn the conference back over to Michael Myers for any closing remarks.

沒有問題，我們的問答環節就結束了。我想將會議轉回邁克爾·邁爾斯進行閉幕致詞。

So just to say thanks to everybody for participating here today. And as always, we are readily available by phone, e-mail. If there are any follow-up questions or concerns, we'd be happy to address them. Other than that, have a great day, and thanks again.

感謝大家今天的參與。一如既往，您可以透過電話、電子郵件隨時與我們聯繫。如果有任何後續問題或疑慮，我們很樂意解決。除此之外，祝你有美好的一天，再次感謝。

The conference has now concluded. Thank you for attending today's presentation. You may all now disconnect.

會議現已結束。感謝您參加今天的演講。你們現在可以斷開連結了。